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Exercise + Multivitamin Supplement for Myotonic Dystrophy (DM1HBET Trial)

Phase 3
Waitlist Available
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months from enrolment
Awards & highlights
Pivotal Trial

Summary

This trial is investigating if exercise and a multivitamin supplement can help people with a genetic muscle disease called "Myotonic dystrophy type 1" (DM1) to improve their symptoms and quality of life.

Who is the study for?
This trial is for men and women aged 19-60 with Myotonic Dystrophy type 1 (DM1), having CTG repeats between 100-1000. Participants should have a BMI of 18.5-29.9, be physically inactive, and able to walk between 250-500 meters in six minutes without severe heart rhythm abnormalities.
What is being tested?
The study tests if a home-based exercise program combined with either a multi-ingredient supplement or placebo can improve muscle function and body composition in DM1 patients over the course of 16 weeks.
What are the potential side effects?
Potential side effects may include typical exercise-related issues like muscle soreness or strain. The multi-ingredient supplement could cause digestive discomfort or allergic reactions, depending on its contents.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months from enrolment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months from enrolment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Body Composition Index
VO2 Max
Secondary study objectives
5x sit to stand
6-minute walk test
Grip strength
+5 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: DM1 + HBEXT + MISActive Control2 Interventions
Participants will be asked to undergo 16 weeks of home-based training and asked to take one dose of a multi-ingredient supplement per day.
Group II: CONTROLActive Control1 Intervention
Healthy control subjects who will not undergo study intervention and will be used for baseline measurements and outcomes.
Group III: DM1 + HBEXT + PLAPlacebo Group2 Interventions
Participants will be asked to undergo 16 weeks of home-based training and asked to take one dose of a multi-ingredient supplement placebo per day.

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
916 Previous Clinical Trials
2,615,168 Total Patients Enrolled

Media Library

Concurrent exercise training Clinical Trial Eligibility Overview. Trial Name: NCT05848830 — Phase 3
Muscular Dystrophy Research Study Groups: DM1 + HBEXT + PLA, DM1 + HBEXT + MIS, CONTROL
Muscular Dystrophy Clinical Trial 2023: Concurrent exercise training Highlights & Side Effects. Trial Name: NCT05848830 — Phase 3
Concurrent exercise training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05848830 — Phase 3
~5 spots leftby Jan 2025
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